Gilead and CRO Quintiles struggle to enrol GS-5745’s Phase II Crohn’s trial with excessive washout period – investigator

19 Jul 2016

Gilead Sciences' (NASDAQ:GILD) GS-5745 (matrix metalloproteinase-9 [MMP-9] inhibitor) is struggling to recruit Crohn's patients into its Phase II study (NCT02405442) following strict inclusion criteria, said a trial investigator. Quintiles (NYSE:Q) is the CRO, the investigator added.

According to ClinicalTrials.gov, patients receiving any monoclonal antibody within four weeks of screening are excluded, however, the investigator said the study protocol actually requires a 16-week washout period from Takeda's (TYO:4502) monoclonal antibody Entyvio (vedolizumab) prior to participant enrolment, slowing the recruitment process.

Consequently, only around three patients have been recruited at the investigator's study centre, said the US-based investigator. No patient dropouts or adverse events have occurred to date at this site, the investigator said.

Gilead did not respond to a request for comment. If approved, analysts predict peak sales of up to USD 900m.

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